Home / Recalls / Zavation / Z-1755-2021

Z-1755-2021 Class II Terminated

Recalled by Zavation — Flowood, MS

Recall Details

Product Type
Devices
Report Date
June 9, 2021
Initiation Date
March 25, 2021
Termination Date
March 20, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
119 units

Product Description

InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.

Reason for Recall

Products distributed as sterile may not have been adequately sterilized

Distribution Pattern

US nationwide distribution.

Code Information

a) INTVMN-10-DSK, Lot Numbers: 12200ZV b) INTVMN-15-DSK, Lot Numbers: 10816ZV, 13708ZV, 13845ZV, 13522ZV, 12133ZV c) INTVMN-15-DSKC, Lot Numbers: 11843ZV, 11412ZV, 11160ZV, 11017ZV d) INTVMN-20-DSK, Lot Numbers: 14266ZV, 14238ZV, 12524ZV, 11756ZV, 11083ZV

Other recalls by Zavation

  • Z-1741-2021 Class II — 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal proc (March 25, 2021)
  • Z-1732-2021 Class II — ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal (March 25, 2021)
  • Z-1704-2021 Class II — ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in O (March 25, 2021)
  • Z-1758-2021 Class II — ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic (March 25, 2021)
  • Z-1727-2021 Class II — 10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal pro (March 25, 2021)
  • Z-1708-2021 Class II — ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK (March 25, 2021)
  • Z-1739-2021 Class II — 11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. (March 25, 2021)
  • Z-1726-2021 Class II — ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For u (March 25, 2021)
  • Z-1715-2021 Class II — 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal pr (March 25, 2021)
  • Z-1728-2021 Class II — ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use i (March 25, 2021)